Phase 2
Completed N=88
A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
Source: ClinicalTrials.gov NCT01358734 ↗Enrolled (actual)
88
Serious AEs
79.8%
Results posted
Jul 2016
Primary outcomePrimary: Kaplan Meier Estimates for One Year Survival — 3.00; 9.61; 13.67 months — p=0.119
Summary
The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan Meier Estimates for One Year Survival |
3.00; 9.61; 13.67 | 0.119 |
| PRIMARY Overall Survival |
0.2; 7.1; 4.1 | — |
| SECONDARY Percentage of Participants With a Complete Response or Morphologic Incomplete Response. |
— | — |
| SECONDARY Duration of Remission (DoR) |
— | — |
| SECONDARY Cytogenetic Complete Remission Rate (CRc) |
— | — |
| SECONDARY Percentage of Participants With an Overall Response Rate (CR +CRi+ PR) |
— | — |
| SECONDARY Progression-Free Survival (PFS) |
— | — |
| SECONDARY Event-Free Survival (EFS) |
— | — |
| SECONDARY Relapse-Free Survival (RFS) |
— | — |
| SECONDARY Percentage of Participants With 30-Day Treatment-Related Mortality |
13.3; 17.9; 5.9 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAE) |
14; 38; 32; 13; 35; 30 | — |
| SECONDARY Number of Participants With a Second Primary Malignancy |
0; 0; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
- Male or female subjects aged ≥ 65
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- White blood cell (WBC) count ≤ 10 x 10⁹/L at screening
Exclusion Criteria
- Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
- Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
- Suspected or proven acute promyelocytic leukemia
- Prior bone marrow or stem cell transplantation
- Candidate for allogeneic bone marrow or stem cell transplantation
- AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
- Presence of malignant disease within the previous 12 months with exceptions
Data sourced from ClinicalTrials.gov (NCT01358734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.